BioLineRx (NASDAQ: BLRX) (TASE: BLRX), a biopharmaceutical development company, have announced the publication of results from the Phase II EAGLE clinical trial for BL-1020, a first in class, orally available, GABA-enhanced antipsychotic for the treatment of schizophrenia, showing that BL-1020 is safe and effective in improving schizophrenia, in addition to improving cognitive impairment associated with this condition. The findings, which were originally announced in September 2009, were published in the September 2012 issue of the Journal of Clinical Psychiatry.

“Significant cognitive impairment is very common in schizophrenia, affecting the great majority of patients, yet currently available antipsychotics have not been effective in treating core cognitive impairment for people suffering from this disease. In fact, two recent landmark studies, in first-episode patients and in chronically ill patients, did not find first- or second-generation antipsychotics to be significantly effective in ameliorating cognitive impairment,” explained Richard Keefe, Ph.D., Professor of Psychiatry and Behavioral Sciences and Psychology at Duke University Medical Center, and co-author of the Paper. “Cognitive impairments are important targets for intervention, as they affect vocational and social functioning and independent living. Therefore, there is a clear need for new antipsychotic drugs that are effective and that improve cognition. In the Phase IIb EAGLE study, BL-1020 shows a clear and significant effect in improving cognitive function in schizophrenia patients.”

The Paper describes the results of the Phase IIb EAGLE study for determining safety, efficacy, and tolerability of low (10 mg/d) and flexible high (20-30 mg/d) doses of BL-1020 compared to Risperidone, an approved atypical schizophrenia drug, and placebo. Results of the study shows that BL-1020 was significantly better than the placebo and comparable with Risperidone in both PANSS and CGI scores, which are widely recognized measures of severity and improvement in schizophrenia. More importantly, the results show a significant improvement in cognitive function as assessed by BACS (Brief Assessment of Cognition in Schizophrenia), when compared to both placebo and Risperidone.

Dr. Kinneret Savitsky, CEO of BioLineRx, stated, “We are pleased with the publication of the EAGLE trial results in a leading scientific journal. Nearly 1% of the world’s population suffers from schizophrenia, which often involves cognitive impairment that may severely undermine daily living skills. Current schizophrenia therapies do not address cognitive impairment, whereas the EAGLE clinical trial shows that BL-1020 significantly enhances cognitive function in schizophrenia patients and therefore has the potential to enhance the functionality and independent living skills of patients with schizophrenia. In order to further validate these results, we are currently conducting the CLARITY clinical trial, which assesses cognition enhancement by BL-1020 as its primary objective. We look forward to the expected results in the second half of 2013.”

About BL-1020

BL-1020 is a first-in-class GABA-enhanced antipsychotic that combines dopamine antagonism with GABAergic activity. BL-1020 has demonstrated high efficacy and safety with minimal EPS and no metabolic side effects. Most importantly, BL-1020 may have the potential to improve cognition, which is a significant unmet medical need in schizophrenia and other neurological/psychiatric disorders. Three clinical studies have confirmed the safety and efficacy of BL-1020, while pre-clinical studies have also shown that BL-1020′s GABA enhancement may provide the basis for improved cognition.

In June 2011, BioLineRx announced commencement of the Phase II/III CLARITY clinical trial of BL-1020. This 450-patient trial aims to determine the short-term (6 weeks) and the long-term (24 weeks) cognitive benefit and anti-psychotic efficacy, safety and tolerability of BL-1020 in schizophrenia patients, compared with Risperidone (one of the leading schizophrenia treatments). The CLARITY trial is proceeding at approximately 30 sites in Romania and India.

About Schizophrenia

Schizophrenia is a serious mental disorder that affects about 1% of the world’s population. It is a multi-factorial disease characterized by delusions and hallucinations, emotional withdrawal and apathy, poor attention and disorganization. The worldwide antipsychotic therapeutic market in 2011 was estimated at approximately $20 billion.